A Proof of Concept Study Comparing Three Doses of an Oral Solution of LEO 22811 With a Placebo Oral Solution for the Treatment of Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01116895
First received: May 4, 2010
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LEO 22811
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An International, Multi-centre, Prospective, Randomised, Double-blind, 4-arm, Placebo Controlled, Parallel Group Study With 12 Weeks Once Daily Oral Treatment in Subjects With Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Percentage change in Psoriasis Area and Severity Index (PASI) from baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects with PASI 75 (i.e. at least 75% reduction in PASI from baseline) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Subjects with "controlled disease" according to the Investigators' Global Assessment (IGA) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Active comparator LEO 22811 Drug: LEO 22811
Oral solution
Active Comparator: 2 Active comparator LEO 22811 Drug: LEO 22811
Oral solution
Active Comparator: 3 Active comparator LEO 22811 Drug: LEO 22811
Oral solution
Placebo Comparator: 4 Placebo comparator Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Following verbal and written information about the trial the subject must provide signed and dated informed consent before any study related activity is carried out, including activities relating to the washout period.
  • Clinical diagnosis of psoriasis vulgaris, for at least 6 months prior to randomisation, and currently covering at least 10% of the body surface area (BSA)
  • Candidates for systemic anti-psoriatic treatment
  • Psoriasis Area and Severity Index (PASI) ≥10
  • Disease severity of moderate, severe or very severe according to the Investigators' Global Assessment of disease severity (IGA)
  • Aged 18 years or above
  • Any race or ethnicity
  • Males, surgically sterile females (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or post menopausal females (at least 1 year since last menses)
  • Attending hospital outpatient clinic or the private practice of a dermatologist

Exclusion Criteria:

  • Systemic treatment with biological therapies whether marketed or not with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

    • Etanercept - 4 weeks
    • Adalimumab, alefacept, infliximab - 2 months
    • Ustekinumab - 4 months
  • Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g.corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporin or fumaric acid) within 4 weeks prior to randomisation
  • PUVA therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Any topical treatment (except for emollients/ medicated shampoo) within 2 weeks prior to randomisation
  • Initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g. beta-blockers, anti-malaria drugs, lithium) 2 weeks prior to randomisation and during the study
  • Current diagnosis with erythrodermic, exfoliative or pustular psoriasis
  • Other current skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator
  • Generally in good health and does not have any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, haematologic, or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study
  • Current active tuberculosis or latent tuberculosis
  • Planned exposure to the sun during the study that may affect psoriasis vulgaris
  • Known malignancy or history of malignancy (other than cervical carcinoma in situ, basal cell or squamous cell carcinoma) within the 5 year period prior to randomisation
  • Live vaccination within the 4 weeks prior to randomisation
  • Males who do not agree to use adequate contraception during the study (including follow-up) to ensure their partner does not become pregnant
  • Known or suspected hypersensitivity to component(s) of the investigational product
  • Current participation in any other interventional trial
  • Treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
  • Previously randomised in this study
  • Known or, in the opinion of the Investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcohol abuse, drug dependency or psychotic state).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116895

Locations
Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Canada, G1V 4X7
France
Hôpital Saint-Louis, Service de Dermatologie
Paris, France
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Yves Poulin, MD Centre de Recherche Dermatologique du Quebec Metropolitain
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01116895     History of Changes
Other Study ID Numbers: LEO 22811-S22
Study First Received: May 4, 2010
Last Updated: September 12, 2011
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by LEO Pharma:
Psoriasis Vulgaris
Systemic
Anti-psoriatic

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014